BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (version 2.5.3 or 2.5.4)882482: BrightView XCT (version 2.5.3 or 2.5.4)882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4) 의 리콜

Recall

RC-2016-RN-00051-1

Class II

2016-01-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00051-1

Philips have identified 4 issues with the brightview systems:1. during a cardiac non-auto body contouring (abc) scan, using cardiac high resolution (chr) collimators, the collimator may come in contact with the bottom edge of the patient pallet. if this occurs, collision sensors would pause the scan. although unlikely, if the collision sensors malfunction & the operator fails to activate the e-stop, this could lead to serious bodily injury for the patient.2. during a scan, the gantry motion may halt prematurely. this causes the scan sequence to pause.3. operator will receive a warning message that the scan may not complete & re-mark the points used to define the orbit when defined with a detector relative angle of 90 & head first supine/feet first prone setting. 4. resolved defects section of user release document 1.2.4/2.5.4 for brightview, brightview x & xct listed 2 pre-programmed motions (ppms) whose motion sequences were changed by the release of s/w v1.2.4/ 2.5.4.

The sponsor will provide a system software upgrade to correct the reported issues.